Merck to Collaborate with Sysmex Inostics on a Blood-Based RAS Biomarker Test

PR56910

DARMSTADT, Germany, June 1 /PRN=KYODO JBN/ -

- Development and commercialization agreement on blood-based RAS biomarker

mutation status test for (metastatic) colorectal cancer (mCRC)  

- This non-invasive, fast and easy-to-perform diagnostic test is expected to

provide a real-time reflection of a patient's RAS mutation status to help guide

clinical decision making in mCRC  

Merck announced today that the company has signed an agreement to collaborate

with Sysmex Inostics GmbH, Hamburg, Germany, for the development and

commercialization of a blood-based RAS biomarker test for patients with

metastatic colorectal cancer (mCRC). This global agreement was formally signed

at a ceremony coinciding with the 50th Annual Meeting of the American Society

of Clinical Oncology (ASCO) in Chicago, U.S.

     (Photo: http://photos.prnewswire.com/prnh/20140601/689906 )

Blood-based biomarker testing is a faster and easier approach for determining

the mutation status of tumors as it requires a small blood sample rather than a

tissue biopsy procedure.[1] The test has the potential to provide mutation

status results within days, which in turn can help guide treatment

decisions.[1] In addition, it may become the method of choice where a tissue

biopsy is difficult to obtain, for example in patients whose physical condition

does not allow for a surgical procedure.

"We are delighted to announce our strategic partnership with Sysmex Inostics,"

said Belen Garijo, President and CEO of Merck Serono. "As a company, we have

embraced the principles of personalized medicine and predictive biomarkers.

This collaboration reflects our commitment to leveraging our expertise in

personalized medicine and predictive biomarkers in order to enhance Erbitux's

value proposition for patients, physicians and payers."

"We are looking forward to this important collaboration with Merck Serono and

to bringing our innovative technology to mCRC patients," said Fernando Andreu,

CEO of Sysmex Inostics. "Together, with our non-invasive, blood-based

diagnostics and Merck's expertise in personalized medicine, we will open up new

possibilities to advance biomarker testing in mCRC.  This collaboration is

another major step in enhancing the clinical value of Sysmex Inostics's

OncoBEAM tests and exemplifies Sysmex's overall strategy to bring sensitive

blood-based testing to the oncology field."

A biomarker test is a simple way of looking at the type and status of

particular genes of interest in a cancer.[2],[3] Biomarkers have been found for

many different types of cancer such as colorectal, breast and lung cancer, and

have an increasingly important role in helping physicians to tailor care and

treatment for their patients, known as 'personalized medicine'.[2-4] RAS

- a predictive biomarker - is a group of genes that includes KRAS

and NRAS and can be used to help select the most appropriate therapy for each

individual mCRC patient.[5-9] Currently, biomarker testing has been

performed with tissue taken directly from the tumor itself, requiring an

invasive biopsy, to ensure that the genes from the tumor can be isolated.

However, recent technological advances embraced by Sysmex using blood samples

allows very small amounts of circulating tumor DNA to be isolated and tested.

"In mCRC, RAS has been identified as a key biomarker that can help predict how

well mCRC patients may respond to particular treatments, making it important to

know their RAS status as early as possible," commented Professor Sabine Tejpar,

Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium. "As

this test is potentially faster and easier to perform, this could mean quicker

and more timely treatment decisions - supporting the ultimate goal of

improved outcomes for patients."

Approximately half of patients with mCRC have RAS wild-type tumors and half

have RAS mutant tumors.[10] Results from studies assessing RAS mutation status

in patients with mCRC have shown that anti-epidermal growth factor receptor

(EGFR) monoclonal antibody therapies, such as Erbitux(R) (cetuximab), can improve

outcomes in patients with RAS wild-type mCRC.[5-9]

About Colorectal Cancer  

Colorectal cancer (CRC) is the second most common cancer worldwide, with an

estimated incidence of more than 1.36 million new cases annually.[11] An

estimated 694,000 deaths from CRC occur worldwide every year, accounting for

8.5% of all cancer deaths and making it the fourth most common cause of death

from cancer.[11] Almost 55% of CRC cases are diagnosed in developed regions of

the world, and incidence and mortality rates are substantially higher in

menthan in women.[11]

References

1. Diaz LA and Bardelli A. J Clin Oncol. 2014;32(6):579-86.

2. Moorcraft SY, et al. Therap Adv Gastroenterol 2013;6(5):381-95.

3. Ong FS, et al. Expert Rev Mol Diagn 2012;12(6):593-602.

4. Mallman MR, et al. EPMA J 2010;1(3):421-37.

5. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.

6. Schwartzberg LS, et al. J Clin Oncol 2014; March 31 [Epub ahead of print].

Available online: http://www.ncbi.nlm.nih.gov/pubmed/24687833. Last accessed

April 2014.

7. Bokemeyer C, et al. Oral presentation at the 2014 American Society of

Clinical Oncology Annual Meeting, May 30-June 3, 2014.

8. Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.

9. Ciardiello F, et al. Oral presentation at the 2014 American Society of

Clinical Oncology Annual Meeting, May 30-June 3, 2014.

10. Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307-12.

11. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M,

Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and

Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France:

International Agency for Research on Cancer; 2013. Available at:

http://globocan.iarc.fr. Last accessed April 2014.

For more information on predictive biomarkers in colorectal cancer, please

visit: http://www.globalcancernews.com.

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic

company whose core competency is mutation detection utilizing highly sensitive

technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of

the most sensitive and quantitative technologies available today for the

detection of tumor specific somatic mutations in blood samples, Sysmex

Inostics' BEAMing services are readily available to support clinical trials and

research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx)

team offers services for the development of non-invasive plasma DNA based IVD

tests supported by a growing network of partners to cover the entire IVD

development process. In addition, BEAMing tests (OncoBEAM) are available

through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters are located in Hamburg, Germany and Sysmex

Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more

information on OncoBEAM blood testing and the BEAMing technology refer to

http://www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Erbitux

Erbitux(R) is a first-in-class and highly active IgG1 monoclonal antibody

targeting the epidermal growth factor receptor (EGFR). As a monoclonal

antibody, the mode of action of Erbitux is distinct from standard non-selective

chemotherapy treatments in that it specifically targets and binds to the EGFR.

This binding inhibits the activation of the receptor and the subsequent

signal-transduction pathway, which results in reducing both the invasion of

normal tissues by tumor cells and the spread of tumors to new sites. It is also

believed to inhibit the ability of tumor cells to repair the damage caused by

chemotherapy and radiotherapy and to inhibit the formation of new blood vessels

inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash

that seems to be correlated with a good response to therapy. In approximately

5% of patients, hypersensitivity reactions may occur during treatment with

Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 90 countries for the

treatment of colorectal cancer and for the treatment of squamous cell carcinoma

of the head and neck (SCCHN).

Merck licensed the right to market Erbitux outside the US and Canada from

ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In

Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and

commercialize Erbitux. Merck has an ongoing commitment to the advancement of

oncology treatment and is currently investigating novel therapies in highly

targeted areas.

About Merck

All Merck Press Releases are distributed by e-mail at the same time they become

available on the Merck Website. Please go to

http://www.merckgroup.com/subscribe to register online, change your selection

or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in

the pharmaceutical and chemical sectors. With its four divisions Merck Serono,

Consumer Health, Performance Materials and Merck Millipore, Merck generated

total revenues of EUR 11.1 billion in 2013. Around 38,000 Merck employees work in

66 countries to improve the quality of life for patients, to further the

success of customers and to help meet global challenges. Merck is the world's

oldest pharmaceutical and chemical company - since 1668, the company has stood

for innovation, business success and responsible entrepreneurship. Holding an

approximately 70 percent interest, the founding family remains the majority

owner of the company to this day. Merck, Darmstadt, Germany is holding the

global rights to the Merck name and brand. The only exceptions are Canada and

the United States, where the company is known as EMD.

SOURCE: Merck KGaA